Minoxidil pharmaceutical foam formulation

Abstract

A pharmaceutical foam formulation in a dosage form which comprises an active ingredient selected from the group consisting of minoxidil, minoxidil sulphate, other soluble minoxidil salts, and mixtures thereof. An embodiment also includes a surfactant, water, and optional further excipients. In an embodiment, the formulation is adapted to form a foam when administered by spraying.

1 . A pharmaceutical formulation, comprising at least one active ingredient selected from the group consisting of minoxidil, minoxidil sulphate, and a soluble minoxidil salt other than minoxidil sulphate, 
 a surfactant; and    water;    said formulation being adapted to form a foam when administered by spraying.    
     
     
         2 . The formulation of  claim 1 , wherein the amount of said surfactant is about 2 to 10% by weight.  
     
     
         3 . The formulation of  claim 1 , wherein said surfactant comprises at least one surfactant selected from the group consisting of an anionic surfactant, a cationic surfactant, a non-ionic surfactant, an amphoteric surfactant, and non-ionic block copolymers.  
     
     
         4 . The formulation of  claim 2 , wherein said surfactant comprises at least one surfactant selected from the group consisting of an anionic surfactant, a cationic surfactant, a non-ionic surfactant, an amphoteric surfactant, and non-ionic block copolymers.  
     
     
         5 . The formulation of  claim 3 , wherein said surfactant is selected from the group consisting of ethoxylated glycerides, ethoxylated sorbitan esters, polyethoxylated and hydrogenated castor oil, non-ionic block copolymers and amphoteric surfactants.  
     
     
         6 . The formulation of  claim 4 , wherein said surfactant is selected from the group consisting of ethoxylated glycerides, ethoxylated sorbitan esters, polyethoxylated and hydrogenated castor oil, non-ionic block copolymers and amphoteric surfactants.  
     
     
         7 . The formulation of  claim 1 , wherein said surfactant is selected from the group consisting of PEG 40 hydrogenated castor oil, Polysorbate 20, cocamidopropyl betaine, glyceryl cocoate, PEG 6 caprylic/capric glycerides and Poloxmer F68.  
     
     
         8 . The formulation of  claim 2 , wherein said surfactant is selected from the group consisting of PEG 40 hydrogenated castor oil, Polysorbate 20, cocamidopropyl betaine, glyceryl cocoate, PEG 6 caprylic/capric glycerides and Poloxmer F68.  
     
     
         9 . The formulation of  claim 1 , wherein when said active ingredient is minoxidil base, said formulation comprises about 50% to about 80% propylene glycol.  
     
     
         10 . A method for administering minoxidil or a salt thereof, consisting of forming a foam containing minoxidil or a salt thereof.  
     
     
         11 . The method of  claim 10 , wherein said foam is formed by spraying through a mesh or nozzle and said foam contains an effective amount of said active ingredient in a volume of about 0.2 cm 3  to about 1.0 cm 3 .  
     
     
         12 . The method of  claim 11 , wherein said foam volume is about 0.3 cm 3  to about 0.6 cm 3 .  
     
     
         13 . The method of  claim 11 , wherein said foam volume is about 0.45 cm 3 .  
     
     
         14 . A spray apparatus for administering minoxidil or a salt thereof, comprising a reservoir, a metered dose valve, and a pharmaceutical formulation comprising at least one active ingredient selected from the group consisting of minoxidil, minoxidil sulphate, and a soluble minoxidil salt other than minoxidil sulphate, 
 a surfactant; and    water;    said formulation being adapted to form a foam when administered by spraying from said apparatus.    
     
     
         15 . The apparatus of  claim 14 , wherein the amount of said surfactant is about 2 to 10% by weight.  
     
     
         16 . The apparatus of  claim 15 , wherein said surfactant comprises at least one surfactant selected from the group consisting of an anionic surfactant, a cationic surfactant, a non-ionic surfactant, an amphoteric surfactant, and non-ionic block copolymers.  
     
     
         17 . The apparatus of  claim 15 , wherein foam dispensed from said apparatus contains an effective amount of said active ingredient in a volume of about 0.2 cm 3 to about 1.0 cm 3 .  
     
     
         18 . The formulation of  claim 17 , wherein when said active ingredient is minoxidil base, and said formulation comprises about 50% to about 80% propylene glycol.  
     
     
         19 . The apparatus of  claim 15 , wherein said surfactant is selected from the group consisting of PEG 40 hydrogenated castor oil, Polysorbate 20, cocamidopropyl betaine, glyceryl cocoate, PEG 6 caprylic/capric glycerides, and Poloxmer F68.  
     
     
         20 . The apparatus of  claim 17 , wherein said surfactant is selected from the group consisting of PEG 40 hydrogenated castor oil, Polysorbate 20, cocamidopropyl betaine, glyceryl cocoate, PEG 6 caprylic/capric glycerides and Poloxmer F68.